FDA Product Code OUK: Surgical Mask With Antimicrobial/antiviral Agent
A Single Use, Disposable Surgical Mask For Occupational Use To Cover The Nose And Mouth Of The Wearer To Protect From The Transfer Of Microorganisms,body Fluids And Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specific Pathogens Under Specified Contact Conditions.
Leading manufacturers include Nbc Meshtec, Inc., Innonix Technologies Limited and Prestige Ameritech.
4
Total
4
Cleared
265d
Avg days
2011
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Surgical Mask With Antimicrobial/antiviral Agent Devices (Product Code OUK)
4 devices
Cleared
Sep 05, 2024
ProGear® Surgical Mask with Oxafence®, Model AV82030
Prestige Ameritech
General Hospital
449d
Cleared
Nov 29, 2019
Innonix Antiviral Child's Face Mask
Innonix Technologies Limited
General Hospital
116d
Cleared
Jan 03, 2019
Cufitec Surgical Mask
Nbc Meshtec, Inc.
General Hospital
97d
Cleared
May 26, 2011
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Filligent Limited
General Hospital
399d
About Product Code OUK - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OUK since 2011, with 4 receiving FDA clearance (average review time: 265 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.